Design Quality Manager

About the Role

In this role, you will lead and develop DELFI's Design Quality, Risk Management, Process Validation, and Equipment Qualification programs from a Quality perspective. You will provide Quality oversight and guidance to ensure compliance and that effective processes are maintained, per applicable regulatory requirements and company procedures. In addition, you will act as a key coordinator of our Regulatory submission documents (e.g., DHFs, Plans, etc.), assessing the requisite documentation from a quality perspective.

What You'll Do

• Provide Design Quality leadership and guidance for product development (includes LDT and IVD), design control (e.g., design and development planning, training, design input, design output, design review, design verification, design validation, design transfer, product design changes, and design history file (DHF)), risk management, change management, process validation/controls, and equipment qualification.
• Provide Design Quality leadership and guidance for IVD product development in compliance with FDA 21 CFR 820 QMSR/ISO 13485
• Support the development teams in aligning our product development execution strategy with Design Control and Risk Management procedures
• Provide guidance, training, review, approve user needs, design input, design control plans, requirements, specifications, protocols/reports, design outputs, design transfer, and risk management documents.
• Lead in partnership with the cross-functional team by facilitating and supporting risk activities, including FMEAs- dFMEA, pFMEA, and use-related risk analysis- from hazard identification through risk control verification and residual risk evaluation. Own the Risk Management Plan and Report, support cross-functional working sessions to current and complete state, and ensure risk file linkage to design outputs, V&V evidence, and labeling.
• Provide support for the preparation of PMA modules/documents and supporting documents to be submitted- including design control and risk management content, and assist in responding to FDA information requests in those areas.
• Drive cross-functional alignment on design documentation. Set consistent standards for the quality of document types, content, lexicon, and level of detail. Ensure DHF design control evidence is submission-ready as it's generated; track/monitor oversight of documentation progress against timelines accordingly
• Lead remediation of existing design and risk documentation. Assess previously created design control and risk management documents and align according to established procedures, design documentation strategy, and documentation standards.
• Support the development teams in aligning our product development execution strategy with our Design Control and Risk Management procedures. Review, approve, and audit Design History File (DHF) elements (e.g., plans, requirements, specifications, test protocols/reports, design traceability, and risk management documents).
• Maintain the section-level inventory of every document required in the DHF, mapped to ISO 13485 with named author, reviewer, approver, and due date for each.
• Review and approve design control, risk management, product change management, production, verification/validation, equipment qualification documents per applicable regulatory requirements and company procedures.
• Provide support for the preparation of pre-submissions, sprints, and PMA modules/documentation.
• Train and mentor cross-functional peers and junior team members on best practices for maintaining compliance with the applicable Quality Management System (QMS) requirements and regulations.
• Author, revise, review, and approve standard operating procedures and other controlled documents.

What You'll Bring to DELFI

• Bachelor's degree in Science, Engineering, or a related field with 8+ years of relevant experience; or Master's degree with 6+ years; or equivalent.
• Experience in Design Quality or a directly related function within the IVD or medical device industry.
• Advanced working knowledge and experience in the application of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
• Demonstrated strategic and tactical leadership building a high-performance results driven team.
• Strong interpersonal and communication skills, including written and verbal communication, and presentation experience.
• Previous experience in a regulated laboratory and product development environment for in-vitro diagnostics (IVD).
• Prior experience with coordinating, reviewing and supporting regulatory submissions.
• Ability to influence, build, and foster relationships horizontally and vertically across the organization.
• Ability to address and resolve a variety of complex issues diplomatically.
• Molecular diagnostics background.